Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery With Light Weight Mesh

NCT ID: NCT00323674

Last Updated: 2023-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2015-08-31

Brief Summary

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This is a prospective randomized study to evaluate the recovery of a hernia inguinalis by a minimally invasive open preperitoneal surgery with polysoft mesh versus a classic open surgery according to modified Lichtenstein procedure with light weight mesh.

Detailed Description

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Conditions

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Hernia, Inguinal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Light Weight Mesh

Group Type ACTIVE_COMPARATOR

Light Weight Mesh

Intervention Type DEVICE

Light Weight Mesh is used.

Polysoft Mesh

Group Type ACTIVE_COMPARATOR

Polysoft Mesh

Intervention Type DEVICE

Polysoft Mesh is used.

Interventions

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Polysoft Mesh

Polysoft Mesh is used.

Intervention Type DEVICE

Light Weight Mesh

Light Weight Mesh is used.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Symptomatic hernia inguinalis
* \> 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederik Berrevoet, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website of the University Hospital Ghent

Other Identifiers

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2006/080

Identifier Type: -

Identifier Source: org_study_id

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